Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma

Not Applicable

Completed

• Conditions: Rectum Adenocarcinoma
• Interventions: Other: Biopsy

• Registration Number: NCT02849158
• Lead Sponsor: Institut Curie

Brief Summary

Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.

Detailed Description

Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-07-29
• Study Start: 2017-06-09
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Middle rectum adenocarcinoma Tumor(T)x Node (N)+ or T3 /T4 N0 or N+
2. Classification done on pelvic Magnetic Resonance Imaging (MRI) and rectal ultrasonography
3. Age ≥ 18
4. No contraindication to treatment with capecitabine
5. Able to receive radiotherapy 50 Grays in 5 weeks
6. No contraindication for surgery after chemoradiotherapy which will be 8 to 10 weeks after completion of chemoradiotherapy
7. Patient or legal representative provided with information and signature of informed consent

Exclusion Criteria

1. High rectum adenocarcinoma
2. Contraindication to rectal biopsy: including anti-coagulants or anti-platelet agents (vitamin K antagonists, clopidogrel, aspirin > 160 grams) that cannot be interrupted
3. Pregnant woman or breastfeeding
4. Persons deprived of their liberty, or under guardianship
5. Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.
6. Patient already included in another therapeutic trial with an experimental medication during the realization of protocol biopsies and surgery
7. Patient not covered by health insurance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsy	Biopsy	Patients will have new biopsy before starting RT-CT and samples will be taken on rectum surgery at the level of the tumor and away from the rectum.

Primary Outcome Measures

Name	Time	Method
Proteomic level evaluation in intra-tumor fibroblast	3 years	Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)

Secondary Outcome Measures

Name	Time	Method
Study of fibroblast impact on colorectal tumor cells (in vitro)	3 years	In vitro analysis including tumor cells characteristics: proliferation, invasive potential, stem cells phenotype).

Trial Locations

Locations (3)

Institut Curie; 🇫🇷 Paris, Ile De France, France

INSTITUT CURIE - Site Paris; 🇫🇷 Paris, France

Institut Curie - Hôpital René Huguenin; 🇫🇷 Saint-Cloud, Ile De France, France